Endometrial CancerPhase 1NCT07444814
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
A Phase 1 study testing HWK-007 in people with Endometrial Cancer and Ovarian Cancer, run by Whitehawk Therapeutics, Inc. at 12 sites in United States.
Trial summary
HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic
- What is being tested?
- HWK-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Dec 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one of the following solid tumor cancers:
- Monotherapy escalation and backfill cohorts:
- non-squamous EGFR-Wt NSCLC
- Endometrial carcinoma
- Platinum Resistant Ovarian Cancer
- Monotherapy expansion cohorts:
- Non-squamous EGFR-Wt NSCLC
- Additional tumor indications to be defined in a future amendment
Who cannot join
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
Show all 9Show fewer
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Central email mailbox - Whitehawk Therapeutics contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
NEXT Oncology - Austin
Austin, Texas, 78758
Sheena Sahota, MD, 737-610-5200, ssahota@nextoncology.com
- Recruiting
Roswell Park Comprehensive Care Center
Buffalo, New York, 14263
Bailey Fitzgerald, MD, 716-845-2300 ext. 8338, bailey.fitzgerald@roswellpark.org
Bailey Fitzgerald, MD
- Recruiting
University Hospital - Cleveland Medical Center
Cleveland, Ohio, 44106
Matthew C Mirsky, MD, 301-980-8969, Matthew.Mirsky2@UHhospitals.org
C
- Recruiting
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, 22031
Alexander Spira, MD, PhD, 571-350-8400, aspira@nextoncology.com
Alexander Spira, MD, PhD
- Recruiting
START - Midwest
Grand Rapids, Michigan, 49546
Manish Sharma, MD, 616-954-5554, manish.sharma@startresearch.com
Manish Sharma
- Recruiting
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, oncologyresearchreferral@hmhn.org
Miguel Gonzalez, MD
- Recruiting
NEXT - Oncology - Houston
Houston, Texas, 77054
Jennifer Segar, MD, 832-384-7900, jsegar@nextoncology.com
Jennifer Segar, MD
- Recruiting
University of Arkansas
Little Rock, Arkansas, 72205-7199
Michael Birrer, MD, MJbirrer@uams.edu
Michael Birrer, MD
- Not yet recruiting
UCLA - Hematology/Oncology Clinical Research Unit
Los Angeles, California, 90095
Aaron Lisberg, MD, 310-352-8252, alisberg@mednet.ucla.edu
Aaron Lisberg, MD
- Recruiting
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, 61637
Michelle C Rowland, MD, 309-308-3350, michelle.rowland@osfhealthcare.org
Michelle Rowland, MD
- Recruiting
START - San Antonio
San Antonio, Texas, 78229
Drew Rasco, MD, 210-593-5258, drew.rasco@startresearch.com
- Not yet recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Lei C Deng, MD, 206-606-4801, ldeng1@fredhutch.org
C
About this study
Official title: A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.
Read the detailed description
The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.
In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).
- Conditions
- Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent, Non-squamous EGFR Wt NSCLC, Platinum Resistant Ovarian Cancer
- Being tested
- HWK-007
- Keywords
- PTK7, Ovarian cancer, Endometrial cancer, NSCLC, Lung cancer, Chemotherapy, ADC, Antibody-Drug-Conjugate, Solid tumor, Phase 1, Ovarian neoplasms, Endometrial neoplasms, Carcinoma, Non Small Cell Lung, Lung neoplasms, Gynecologic cancer, EGFR Wt NSCLC, Platinum Resistant Ovarian Cancer, DNA Topoisomerase I
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HWK-007Drug
Also called HWK-007 anti-PTK7 targeted ADC
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - 21 Day treatment cycle | Experimental | Escalating doses of HWK-007 administered intravenously (IV) Receives: Drug: HWK-007 |
| Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC | Experimental | Expanded enrolment at selected dose of HWK-007 in NSCLC. Receives: Drug: HWK-007 |
| Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | Experimental | Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD Receives: Drug: HWK-007 |
| Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | Experimental | Expanded enrolment at third selected dose in Tumor - TBD Receives: Drug: HWK-007 |
| Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | Experimental | Dose Expansion of HWK-007, a PTK7-directed ADC. Receives: Drug: HWK-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Maximum Tolerated Dose (MTD)
Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Measured: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
Determine Maximum Administered Dose (MAD)
Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Measured: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
Determine the Recommended Dose for Expansion (RDE)
Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Measured: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.
Secondary outcomes (13)
Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Pharmacokinetic analysis of HWK-007 in human subjects
Measured: Cycle 1 and Cycle 4 (21-day cycles)
Assess ADA (Anti drug antibody) against HWK-007
Using a blood test, determine the risk of developing anti-drug antibodies against HWK-007 following infusion in human patients.
Measured: Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.
Evaluate the Overall Response Rate (ORR)
Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1
Measured: From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.
Evaluate Overall Survival (OS).
Measure how long patient lives following treatment with HWK-007
Measured: From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.
Maximum Concentration - Cmax of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Maximum amount of study drug and drug components in blood following infusion.
Measured: At Cycle 1 and Cycle 4 - (21-day cycles)
Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time to reach maximum concentration of drug and drug components in blood following infusion.
Measured: At Cycle 1 and Cycle 4 (21-day cycles).
Area Under the Concentration Time Curve (AUC) for HWK-007 (ADC, total antibody, CPT116, and CPT119)
The total area under the concentration time curve of study drug and drug components following infusion.
Measured: Cycle 1 and Cycle 4 - (21-day cycles)
T1/2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time for 1/2 of the infused drug to be eliminated/metabolized
Measured: Cycle 1 and Cycle 4 (21-day cycles)
Clearance (CL)
Measured rate at which HWK-007 is cleared from the blood following infusion.
Measured: Cycle 1 and Cycle 4 (21-day cycles)
Evaluate the Duration of Response (DoR) to HWK-007
Measure the time from evidence of response by CT-scan until evidence of progression of cancer.
Measured: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Evaluate Progression-free Survival (PFS)
Measure the time from the first infusion of HWK-007 until evidence of cancer progression is detected.
Measured: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)
Evaluate Disease control Rate (DCR)
Measure the time from Cycle 1, Day 1 that cancer does not worsen by RECIST1.1 criteria.
Measured: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Time to Response (TTR)
Time from Cycle 1, Day 1 infusion of HWK-007 until evidence of response via CT scan according to RECIST1.1 criteria.
Measured: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start19 Dec 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study employs a sequential dose escalation and dose expansion design without a control group
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whitehawk Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret C Dugan, MD, Study director, Whitehawk TherapeuticsAllison Upalawanna, Study director, Whitehawk Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444814
- Sponsor's protocol ID
- HWK-007-101
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07444814
- Acronym / sponsor ID
- HWK-007-101
- Conditions
- Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent, Non-squamous EGFR Wt NSCLC, Platinum Resistant Ovarian Cancer
- Keywords
- PTK7, Ovarian cancer, Endometrial cancer, NSCLC, Lung cancer, Chemotherapy, ADC, Antibody-Drug-Conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Whitehawk Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.
Detailed description
The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.
In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study employs a sequential dose escalation and dose expansion design without a control group
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - 21 Day treatment cycle | Experimental | Drug: HWK-007Escalating doses of HWK-007 administered intravenously (IV) |
| Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC | Experimental | Drug: HWK-007Expanded enrolment at selected dose of HWK-007 in NSCLC. |
| Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-007Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD |
| Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-007Expanded enrolment at third selected dose in Tumor - TBD |
| Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-007Dose Expansion of HWK-007, a PTK7-directed ADC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Monotherapy escalation and backfill cohorts:
- Monotherapy expansion cohorts:
Key exclusion criteria (9 listed)
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HWK-007Also: HWK-007 anti-PTK7 targeted ADCHWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors. | Drug | Dose Escalation - 21 Day treatment cycle, Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC, Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD, Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD, Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD |
Primary outcome
Determine Maximum Tolerated Dose (MTD)
Time frame: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Determine Maximum Administered Dose (MAD)
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Determine the Recommended Dose for Expansion (RDE)
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.
Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
13 secondary outcomes
Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Assess ADA (Anti drug antibody) against HWK-007
Time frame: Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.
Evaluate the Overall Response Rate (ORR)
Time frame: From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.
Evaluate Overall Survival (OS).
Time frame: From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.
Maximum Concentration - Cmax of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time frame: At Cycle 1 and Cycle 4 - (21-day cycles)
Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time frame: At Cycle 1 and Cycle 4 (21-day cycles).
Area Under the Concentration Time Curve (AUC) for HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 - (21-day cycles)
T1/2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Clearance (CL)
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Evaluate the Duration of Response (DoR) to HWK-007
Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Evaluate Progression-free Survival (PFS)
Time frame: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)
Evaluate Disease control Rate (DCR)
Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Time to Response (TTR)
Time frame: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Central email mailbox - Whitehawk Therapeutics contact
Margaret C Dugan, MD study director
Whitehawk Therapeutics
Allison Upalawanna study director
Whitehawk Therapeutics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HWK-007 in people with Endometrial Cancer and Ovarian Cancer, run by Whitehawk Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager Lead (866-742-9495, WHWK-Clinical-Trials@whitehawktx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Maximum Tolerated Dose (MTD) (time frame: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.